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Digg It - Setting a Pitiful Example: Twenty-six Warnings to Heed *
TO: All Parents [and Employers and Managers]
From: Your Child and/or Employee
Date: The present time
Re: Don't Spoil me; Teach Me
1. Don't
From: Your Child and/or Employee
Date: The present time
Re: Don't Spoil me; Teach Me
1. Don't
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
spoil me. I know quite well that I ought not to have all I ask for. I'm only testing you.
2. Don't be afraid to be firm with me. I prefer it; it lets me know where I stand.
3. Don'
2. Don't be afraid to be firm with me. I prefer it; it lets me know where I stand.
3. Don'
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
use force with me. It teaches me that power is all that counts; I will respond more readily to being led.
4. Don't be inconsistent. It confuses me and makes me try harder to get awa
4. Don't be inconsistent. It confuses me and makes me try harder to get awa
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
with everything that I can.
5. Don't make promises you cannot keep them. It will discourage my trust in you.
6. Don't fall for my provocations when I say and do things just to ups
5. Don't make promises you cannot keep them. It will discourage my trust in you.
6. Don't fall for my provocations when I say and do things just to ups
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
t you. Then I will try for more such "victories".
7. Don't be too upset when I say, "I hate you". I don't mean it, but I want you to feel sorry for what you have done to me.
8. Don
7. Don't be too upset when I say, "I hate you". I don't mean it, but I want you to feel sorry for what you have done to me.
8. Don
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t make me feel smaller than I am. I will make up for it by behaving like a "big shot".
9. Don't do things for me that I can do for myself. It makes me feel like a baby and I may cont
9. Don't do things for me that I can do for myself. It makes me feel like a baby and I may cont
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
nue to put you in my service.
10. Don't correct me in front of people. I'll take much more notice when you talk quietly with me in private.
11. Don't try to discuss my behavior in th
10. Don't correct me in front of people. I'll take much more notice when you talk quietly with me in private.
11. Don't try to discuss my behavior in th
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
heat of conflict. For some reason my hearing is not very good at this time and my cooperation is even worse. It’s all right to take the action required, but let's not talk about it un
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
il later.
12. Don't try to preach to me. You’d be surprised how well I know what's right and wrong.
13. Don't make me feel that my mistakes are sins. I have to learn to make mistakes
12. Don't try to preach to me. You’d be surprised how well I know what's right and wrong.
13. Don't make me feel that my mistakes are sins. I have to learn to make mistakes
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
without feeling that I am no good.
14. Don't nag. When you do, I shall have to protect myself by appearing deaf.
15. Don't demand explanations for my wrong behavior. I really don't k
14. Don't nag. When you do, I shall have to protect myself by appearing deaf.
15. Don't demand explanations for my wrong behavior. I really don't k
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ow why I did it.
16. Don't tax my honesty too much. I am easily frightened into telling lies.
17. Don't forget that I love and use experimenting. I learn from it; so put up with it.
16. Don't tax my honesty too much. I am easily frightened into telling lies.
17. Don't forget that I love and use experimenting. I learn from it; so put up with it.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
18. Don't take too much notice of my small ailments. I may learn to enjoy poor health when it gets me much attention.
19. Don't protect me from consequences. I need your guidance to
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
learn from my experiences.
20. Don't put me off when I ask honest questions. When you continue to do so, you'll find that I'll stop asking and start seeking my information elsewhere.
20. Don't put me off when I ask honest questions. When you continue to do so, you'll find that I'll stop asking and start seeking my information elsewhere.
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
21. Don't answer my "silly" or meaningless questions. I just want you to keep busy with me.
22. Don't ever think that it is beneath your dignity to apologize to me. An honest apology
22. Don't ever think that it is beneath your dignity to apologize to me. An honest apology
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
akes me feel surprisingly warm toward you.
23. Don't ever suggest that you are perfect or infallible. It gives me too much to live up to.
24. Don't worry about the little amount of t
23. Don't ever suggest that you are perfect or infallible. It gives me too much to live up to.
24. Don't worry about the little amount of t
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
me we spend together. It is HOW we spend it that counts.
25. Don't let my fears arouse your anxiety; then I shall be afraid. Show me courage instead.
26. Don't forget that I can't th
25. Don't let my fears arouse your anxiety; then I shall be afraid. Show me courage instead.
26. Don't forget that I can't th
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ive without lots of understanding and encouragement. But I don't need to tell you that, do I?
Treat me with respect the way you treat your friends, then I'll be your respectful friend
Treat me with respect the way you treat your friends, then I'll be your respectful friend
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
too. I learn more from a model than from a critic.
Remember: When you maximize your potential, everyone wins. When you don't, we all lose.
* Adapted from Memorandum fro
Remember: When you maximize your potential, everyone wins. When you don't, we all lose.
* Adapted from Memorandum fro
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
Your Child, author anonymous.
--
PERMISSION TO REPUBLISH: This article may be republished in newsletters and on web sites provided attribution is provided to the auth
--
PERMISSION TO REPUBLISH: This article may be republished in newsletters and on web sites provided attribution is provided to the auth
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
r, and it appears with the included copyright, resource box and live web site link. Email notice of intent to publish is appreciated but not required. Mail to: eagibbs@ureach.com
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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